PORCELANA SKIN LIGHTENING NIGHTTIME HYDRATION- hydroquinone cream
CCA Industries Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Porcelana Skin Lightening Cream Nighttime Hydration

Drug Facts

Active Ingredient

Hydroquinone U.S.P. 2%

Purpose

Skin Lightener

Uses:

For the gradual fading of dark spots in the skin such as age liver spots and pigment in the skin that may occur in pregnancy or from the use of oral contraceptives.

Warnings

For External use only. Avoid contact with eyes.

Do not use

on children under 12 years of age unless directed by a doctor.

When using this product

some users may experience a mild skin irritation.

Stop use and ask a doctor

if skin irritation becomes severe.

Keep out of the reach of children.

If swallowed, seek medical help or contact a Poison Control Center right away.

Sun exposure should be limited by using a sunscreen agent: a sun blocking agent or protective clothing to cover bleached skin after treatment is completed to prevent darkening from reoccurring.

Directions

Adults apply a small amount as a thin layer on the affected area(s) as part of your nighttime routine or as directed by a doctor. For best results, use with Porcelana Night. If no improvement is seen after three months of treatment, use of this product should be discontinued.

Other Information

Lightening effect of this product may not be noticeable when used on very dark skin.

Inactive Ingredients

Water, Mineral Oil, Glyceryl Stearate, Cetyl Alcohol, Isopropyl Palmitate, PEG-100 Stearate, Propylene Glycol, Emulsifying Wax NF, Stearic Acid, Hydroxyethylcellulose, Disodium EDTA, Sodium Metabisulfite, Fragrance, Diazolidinyl Urea, Persea Gratissima (Avocado) Oil, Methylparaben, Propylparaben, BHT, Magnesium Ascorbyl Phosphate, Tocopheryl (Vitamin E) Acetate, Retinyl (Vitamin A) Palmitate, Citric Acid

Questions or Comments?

Call toll-free: 1-888-681-1840
Visit us at www.porcelana.com

Package Labeling:

Label3

PORCELANA SKIN LIGHTENING NIGHTTIME HYDRATION
hydroquinone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61543-0002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	20 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETYL ALCOHOL (UNII: 936JST6JCN)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
PEG-100 STEARATE (UNII: YD01N1999R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
AVOCADO OIL (UNII: 6VNO72PFC1)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61543-0002-0	1 in 1 BOX	02/15/1974	04/13/2022
1		85 g in 1 JAR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part358A	02/15/1974	04/13/2022

Labeler - CCA Industries Inc. (106771041)

Revised: 7/2022

Document Id: e45422d8-9f95-519e-e053-2995a90adfb1

Set id: 178f6ee0-363c-46b9-8b9b-d635c4f38241

Version: 2

Effective Time: 20220721

CCA Industries Inc.